Examining Hepatitis C Reinfection Rates in Kenya

Hepatitis C Clinical Trial

Official title:

Hepatitis C Reinfection in an Injection Drug Using Population in Kenya: A Follow-up to the TLC-IDU Hepatitis C V Supplement Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03564639
• Other study ID #: 1512016965_B
• Status: Completed
• Start date: October 1, 2019
• Est. completion date: February 1, 2021

Study information

• Verified date: April 2021
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The goal of this research project is to build upon the Testing and Linkage to Care for Injecting Drug Users (TLC-IDU) parent study and describe post-cure HCV reinfection in a population of people who inject drugs (PWIDs) in Kenya.

Description:

In addition to describing reinfection in a substance using cohort, we will identify individual predictors of HCV reinfection in Kenya, as well as identifying individual utilization intervention approaches and dosing that reduce reinfection risk and treatment cite level risk factors (frequency of visits, community vs hospital location etc.). Determining the risk factors specific to reinfection and understanding the impact of concurrent harm reduction interventions will guide service delivery and implementation of HCV elimination strategies in Kenya and throughout the region.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: February 1, 2021
• Est. primary completion date: February 1, 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Live in Nairobi or coastal Mombasa (Coast Province including Malindi), Kenya;

2. Are injection drug users (IDUs) that ever injected any non-prescribed drugs; and able and willing to provide informed consent.

3. Participates are in the parent study;

4. Complete treatment protocol; and achieve a sustained virologic response (SVR).

Exclusion Criteria:

Not in the above inclusion criteria.

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C

Locations

Country	Name	City	State
Kenya	NASCOP	Nairobi

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HCV Reinfection	The reinfection of patients with hepatitis C after completion of a previous HCV infection treatment.	6-18 months post sustained virologic response (SVR) to HCV treatment.
Primary	Evaluate psychoeducational counseling	Brief questionnaire on knowledge, attitude and beliefs of each participant.	6 months
Primary	Examine usage of methadone maintenance	Brief questionnaire on services used	12 months
Primary	Examine usage of needle exchange programs	Brief questionnaire on services used	12 months
Primary	Evaluate psychoeducational counseling	Brief questionnaire on knowledge, attitude and beliefs of each participant.	12 months
Secondary	HCV reinfection referrals for treatment at Kenyetta National Hospital	Confirmed HCV reinfection cases will receive referrals to Kenyatta National Hospital and Coast General Hospital for treatment and management.	9-16 months post treatment